Anakinra in Dengue With Hyperinflammation ( AnaDen )

PHASE2RecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

January 2, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
DengueDengue With Warning SignsSevere DengueAnakinraImmuno-modulationAnti-inflammatory AgentsMacrophage Activation SyndromeHyperinflammatory SyndromeCytokine Storm
Interventions
DRUG

Placebo

"Drug: Placebo, with visually matched clear syringes~* Adults (≥16 years) and children (12-16 years, \> 50Kg) will receive 2 syringes of placebo via IV route, twice daily for 4 days~* Children (12-16 years, \< 50Kg) will receive no more than 1 syringe of placebo via IV route, twice daily for 4 days"

DRUG

Anakinra

"Drug: Anakinra~* Adults (≥16 years) and children (12-16 years, \> 50Kg) will receive 200mg of anakinra (2 syringes) via IV route, twice daily for 4 days~* Children (12-16 years, \< 50Kg) will receive 2mg/Kg of anakinra via IV route, twice daily for 4 days (no more than 1 syringe of anakinra, twice daily for 4 days)"

Trial Locations (1)

Unknown

RECRUITING

Hospital for Tropical Diseases, Ho Chi Minh City

All Listed Sponsors
collaborator

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

OTHER

collaborator

Wellcome Trust

OTHER

lead

Oxford University Clinical Research Unit, Vietnam

OTHER